Centers for Disease Control and Prevention

Proposed Clinical Consideration Updates for 

Nirsevimab

Jefferson Jones MD MPH FAAP, CDR USPHS

Co-Lead, Respiratory Syncytial Virus Vaccines - Pediatric/Maternal Work Group 

Coronavirus and Other Respiratory Viruses Division

National Center for Immunization and Respiratory Diseases

August 3, 2023
2

Timing of nirsevimab

▪ Providers should target administration1:

– In the first week of life for infants born shortly before and during the season

– Shortly before the start of the RSV season for infants aged <8 months

– Shortly before the start of the RSV season for children aged 8–19 months who 

are at increased risk of severe RSV disease

▪ Based on pre-pandemic patterns, this means nirsevimab could be administered in 

most of the continental United States from October through the end of March

▪ Because timing of the onset, peak, and decline of RSV activity may vary, providers 

can adjust administration schedules based on local epidemiology

1 While optimal timing for nirsevimab administration is shortly before the season, nirsevimab may be given at any time during the RSV season for ageeligible infants and children who have not yet received a dose
3

Timing of nirsevimab for infants born shortly before or 

during RSV season

▪ Nirsevimab should be administered within 1 week of birth.

– Administration can be during the birth hospitalization or in the 

outpatient setting

▪ Infants with prolonged birth hospitalizations due to prematurity or other 

causes should receive nirsevimab shortly before or promptly after 

discharge 
4

Tropical climates and Alaska

▪ Tropical climates may have seasonality that differs from most of the 

continental United States or is unpredictable 

– May include southern Florida, Hawaii, Guam, Puerto Rico, U.S. Virgin 

Islands, and U.S.-Affiliated Pacific Islands

▪ In Alaska, RSV seasonality is less predictable, and the duration of RSV 

seasons is often longer than the national average

▪ Providers in these jurisdictions should consult state, local, or territorial 

guidance on timing of nirsevimab administration
5

Coadministration with routine childhood vaccines

▪ In accordance with CDC’s general best practices for immunizations, 

simultaneous administration of nirsevimab with age-appropriate vaccines 

is recommended

▪ In clinical trials, when nirsevimab was given concomitantly with routine 

childhood vaccines, the safety and reactogenicity profile of the 

coadministered regimen was similar to the childhood vaccines given alone1

▪ When coadministered, nirsevimab is not expected to interfere with the 

immune response to vaccines2

1FDA label for nirsevimab ; 2Espocito Front Immunol. 2021 Aug 11;12:708939. 
6

Children aged 8–19 months recommended to receive 

nirsevimab when entering their second RSV season because of 

increased risk of severe disease 

▪ Children with chronic lung disease of prematurity who required medical 

support (chronic corticosteroid therapy, diuretic therapy, or supplemental 

oxygen) any time during the 6-month period before the start of the second 

RSV season

▪ Children with severe immunocompromise 

▪ Children with cystic fibrosis who have manifestations of severe lung 

disease (previous hospitalization for pulmonary exacerbation in the first 

year of life or abnormalities on chest imaging that persist when stable) or 

weight-for-length <10th percentile

▪ American Indian and Alaska Native children
7

Nirsevimab recommendations for infants and children 

at increased risk of severe RSV

▪ Nirsevimab is recommended for infants aged <8 months born during or 

entering their first RSV season, including those recommended to receive 

palivizumab by AAP1

▪ Nirsevimab is recommended for children aged 8–19 months who are at 

increased risk of severe RSV disease and entering their second RSV season, 

including those recommended to receive palivizumab by AAP1

▪ Per FDA label, children who have received nirsevimab should not receive 

palivizumab for the same RSV season2

1American Academy of Pediatrics. Committee on Infectious Diseases [Respiratory Syncytial Virus.] In: Kimberlin DW, Barnett ED, Lynfield R, Sawyer MH, eds. Red Book 

: 2021 Report of the Committee on Infectious Diseases. Itasca, IL: American Academy of Pediatrics, 2021.

2FDA label for nirsevimab
8

Precautions and Contraindications

▪ Providers administering nirsevimab should follow ACIP's general best 

practice guidelines for immunization1

▪ Nirsevimab should not be administered to persons with a history of severe 

allergic reaction (e.g., anaphylaxis) after a previous dose or to a product 

component (contraindication) 

1 For immunization information systems, state or local guidance should be followed
9

Consumers and health care providers reporting 

suspected adverse reactions for nirsevimab

▪ Report suspect adverse reactions following the administration of 

nirsevimab without coadministration with any vaccine to MedWatch 

– Reports can be submitted to MedWatch online at 

www.fda.gov/medwatch or by phone at 1-800-FDA-1088

▪ Report suspect adverse reactions following co-administration of nirsevimab 

with any vaccine to the Vaccine Adverse Event Reporting System (VAERS)

– Please specify that the patient received nirsevimab on the VAERS form, 

specifically, in Section 9: ‘Prescriptions, over-the-counter medications, 

dietary supplements, or herbal remedies being taken at the time of 

vaccination’
10

Acknowledgements 

Meredith McMorrow

Lauren Roper

Katherine Fleming-Dutra

Mila Prill

Amanda Payne

Danielle Moulia

Morgan Najdowski

David Hutton

Jamie Pike

Ismael Ortega-Sanchez

Andrew Leidner

Sara Oliver

Monica Godfrey

Evelyn Twentyman

Rebecca Morgan

Doug Campos-Outcalt

Sherry Farr

Karrie Finn-Downing

Melissa Glidewell

Eric Griggs

Emilia (Emily) Koumans

Matt Oster

Eghosa (Ivy) Oyegun

Francena Scott

Olga Varechtchouk

Lori Moore

Roua El Kalach

Eric Larson

Harris LaTreace

Michelle Ruslavage

Hannah Rosenblum

James Singleton

Carla Black

Sarah Meyer

Derrell Powers

Raigan Wheeler

Michael Melgar

Amadea Britton

Erica Reott

Samuel Graitcer

Jeanne Santoli

Jill Moses

Jamie Mells

Dawona Hough

Paul Lucas

Michelle Banks

Arthur Bayo

Nancy Fenlon

Rebecca Miller

Elizabeth Walker

Suzanne Johnson-DeLeon

JoEllen Wolicki

Elizabeth Greene

Neil Murthy

Patricia Wodi

Sarah Cutchin

Elisha Hall

Sarah Schillie

Andrew Kroger

Melissa Barnett

Dale Babcock

Rosa Herrera

Richard Quartarone

Stuart Myerburg

Melissa Taylor

Sarah Morales

Barbara Mahon

All members of the ACIP 

Mat/Peds RSV Workgroup
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.
Centers for Disease Control and Prevention

Workgroup Considerations and Voting 

Language for Nirsevimab

Jefferson Jones MD MPH FAAP, CDR USPHS

Co-Lead, Respiratory Syncytial Virus Vaccines - Pediatric/Maternal Work Group 

Coronavirus and Other Respiratory Viruses Division

National Center for Immunization and Respiratory Diseases

August 3, 2023
13

Safety monitoring for nirsevimab

▪ FDA will monitor safety reports submitted by patients, providers, and the 

manufacturer to the FDA Adverse Event Reporting System (FAERS) and 

Vaccine Adverse Event Reporting System (VAERS)

▪ FDA will monitor other data sources, including the scientific literature, 

applicant’s periodic safety reports, ongoing clinical studies, and potentially 

other sources (e.g., medical billing and electronic health records)

▪ CDC will monitor reports submitted to VAERS that involve simultaneous 

administration of nirsevimab with childhood vaccines and will also monitor 

the safety of nirsevimab in the Vaccine Safety Datalink (VSD)

June 8, 2023 Meeting of the Antimicrobial Drugs Advisory Committee- FDA Presentations
14

Effectiveness monitoring for nirsevimab

▪ CDC will leverage existing COVID-19 vaccine effectiveness (VE) platforms

▪ New Vaccine Surveillance Network (NVSN)

– Active surveillance network for acute respiratory infection at 7 pediatric medical centers that 

can assess effectiveness against outpatient and emergency department visits and 

hospitalization

– Capture nirsevimab receipt through parent interview, medical record review at the primary 

care provider and birth hospital, and state immunization information systems (IIS)

▪ Virtual SARS-CoV-2, Influenza, and Other respiratory viruses Network (VISION)

– Multi-site, electronic healthcare record-based network that can assess effectiveness against 

emergency department/urgent care visits, hospitalization, and critical illness

– Nirsevimab effectiveness analyses will be limited to integrated healthcare system sites that will 

have more complete capture of nirsevimab receipt (i.e., through IIS linkage and claims data)

▪ CDC will monitor nirsevimab effectiveness throughout the season, but end of season estimates will 

likely be most accurate. Power to estimate effectiveness depends on uptake and RSV incidence
15

RSV genomic surveillance

▪ Mutations resulting in nirsevimab resistance have been rarely reported1,2

▪ Sanofi and AstraZeneca sponsoring INFORM-RSV, a global genomic 

surveillance study in children aged < 5 years to monitor evolution of RSV 

strains, F protein antigenic sites, and their relationships with clinical 

features of RSV disease3

▪ CDC planning genomic RSV surveillance of pediatric and adult RSV 

specimens, including whole genomic surveillance

– Will monitor for changes in F protein that might result in nirsevimab 

resistance

1Ahani et al. Nat Comm 2023 14:4347; 2Wilkins et al. Lancet Infect Dis 2023; 23: 856–66; 3Tabor 2020 Dec 17;59(1):e01828-20.
16

Work Group considerations for infants aged <8 months 

born during or entering RSV season

▪ Nirsevimab is safe and effective in reducing the risk of RSV disease, including 

hospitalization due to RSV

▪ Shared concerns as outlined in implementation considerations presentation

▪ Use of nirsevimab would be a reasonable and efficient allocation of resources 

– Many work group members prefer lower cost per dose
17

Work Group considerations for children aged 8–19 

months who are at increased risk of severe RSV disease 

and entering their second RSV season 

▪ Limited efficacy and safety data for the use of nirsevimab for children in their 

second RSV season

▪ Limited data on the burden of severe disease in the second RSV season for children 

with chronic conditions

▪ Support recommendation of nirsevimab being given to children aged 8–19 months 

who are entering their second RSV season for those who are recommended for 

palivizumab by American Academy of Pediatrics in their second RSV season and for 

American Indian and Alaska Native children
18

Proposed ACIP Voting Language

▪ Infants aged <8 months born during or entering their first RSV season are 

recommended to receive one dose of nirsevimab (50 mg for infants <5 kg 

and 100 mg for infants ≥5 kg)

▪ Children aged 8–19 months who are at increased risk of severe RSV disease 

and entering their second RSV season are recommended to receive one 

dose of nirsevimab (200 mg) 
For more information, contact CDC

1-800-CDC-INFO (232-4636)

TTY: 1-888-232-6348 www.cdc.gov

The findings and conclusions in this report are those of the authors and do not necessarily represent the 

official position of the Centers for Disease Control and Prevention.